FDA Pulls Emergency Use Authorization for Hydroxychloroquine for COVID-19 Treatment

FDA Revokes Emergency Use Authorization:

On June 15, 2020, the Food and Drug Administration (FDA) rescinded the Emergency Use Authorization (EUA) allowing hospital patients to use certain malaria medications such as hydroxychloroquine and chloroquine for treating COVID-19. The announcement warned that these medicines “are unlikely to be effective in treating COVID-19 for the authorized use in the EUA” and that “the totality of scientific evidence currently available indicate a lack of benefit.”

Furthermore, the announcement also cited a non-clinical study that administered the two drugs along with Gilead’s remdesivir COVID-19 medication and the presence of the malaria drugs “may result in reduced antiviral activity of remdesivir.”

Why Did the FDA Revoke the Emergency Use Authorization?

The FDA stated in their announcement: “In light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits” of hydroxychloroquine no longer outweigh those risks.”

The June 15 announcement comes less than 2 months after the FDA warned patients and caregivers that hydroxychloroquine and chloroquine have been linked to life-threatening heart rhythm problems. The FDA reiterated this warning in the June 15 announcement, stating that hydroxychloroquine and chloroquine have been connected to “ongoing serious cardiac adverse events and other potential serious side effects.”

March 2020

The EUA was first issued in March 2020 and applied to patients who were hospitalized with COVID-19 and those in clinical trials. However, in April the FDA warned doctors against prescribing the drug to COVID-19 patients outside of hospitalization and clinical trial conditions.

Since the FDA granted the EUA, researchers have reported that patients treated with the medications have died at a higher rate than those receiving regular treatment for COVID-19.

April 2020

In April 2020, the FDA issued a warning telling patients and caregivers that malaria drugs (such as hydroxychloroquine and chloroquine) have been reported to have serious and life-threatening side effects when used to treat the disease. The announcement also included the warning that patients with other health issues, such as heart and kidney disease, are likely to be at an increased risk of heart problems when taking hydroxychloroquine and chloroquine.

June 2020

Just prior to the June 15 announcement, research from the University of Minnesota Medical School published in the New England Journal of Medicine found that hydroxychloroquine was no more effective than a placebo at preventing COVID-19 symptoms among people exposed to coronavirus.

This is the first major clinical trial analyzing whether the medication might be useful as a prophylactic. The study focused on 821 people who had been in close contact with a confirmed COVID-19 patient—putting those 821 people at an increased risk of developing COVID-19 themselves.

Study participants were sent doses of either hydroxychloroquine or a placebo and asked to take the pills for two weeks. The study was double-blind—neither the study participants nor the researchers knew in advance which people would be getting the real medication.

At the end of the two weeks, there was virtually no difference in who developed COVID-19 symptoms. 12% of those given hydroxychloroquine reported symptoms, compared with 14% of those who were given a placebo.

What is Hydroxychloroquine and What Does It Do?

Hydroxychloroquine is a drug traditionally used to treat malaria and certain autoimmune conditions, such as lupus and rheumatoid arthritis. However, the FDA’s June 15 announcements do not apply to the drug’s treatment of these conditions.

Hydroxychloroquine first gained attention as a potential COVID-19 treatment in February 2020 when two small studies suggested that it might be useful against the COVID-19 virus.

President Donald Trump encouraged its use, even saying in May 2020 that he took hydroxychloroquine to prevent COVID-19.

How Do I Know If I Have Been Harmed?

Common Side Effects Include:

  • Headache
  • Dizziness
  • Diarrhea
  • Stomach cramps
  • Vomiting

Serious Side Effects:

  • Blurred vision or other vision changes (may be permanent in some cases)
  • Heart disease, heart failure, issues with heart rhythm (some cases have been fatal)
  • Ringing in your ears or hearing loss
  • Angioedema (rapid skin swelling)
  • Hives
  • Mild or severe bronchospasm (tightening of muscles that line the lungs’ airways)
  • Persistent sore throat
  • Hypoglycemia (low blood sugar)
  • Unusual bleeding or bruising
  • Blue-black skin color
  • Muscle weakness
  • Hair loss or changes in hair color
  • Abnormal mood changes
  • Mental health effects, including suicidal thoughts

Symptoms of Heart Disease, Heart Failure, and Heart Rhythm Issues:

  • Shortness of breath
  • Swelling of ankles/feet
  • Unusual tiredness
  • Unusual/sudden weight gain
  • Symptoms of Hypoglycemia (low blood sugar)

Symptoms of Hypoglycemia (low blood sugar)

  • Sudden sweating or shaking
  • Hunger
  • Blurred vision
  • Dizziness
  • Tingling hands or feet

How GoldenbergLaw Can Help You

The attorneys at GoldenbergLaw have handled dangerous drug cases for more than 30 years and will provide you with the Gold standard of advocacy that you deserve.

 

Elmiron Side Effects: Maculopathy

What are the Elmiron Lawsuits About?

Lawsuits against the common bladder medication Elmiron claim that the drug causes an eye disorder known as maculopathy and other disorders within the retina (the light-sensing tissue located at the back of the eye that enables us to see) and may lead to blindness. The lawsuits also allege that the manufacturer of Elmiron, Janssen Pharmaceuticals (a subsidiary of Johnson & Johnson), failed to properly warn the public about the risk of vision problems.

What is Elmiron Supposed to Treat?

Elmiron is a drug intended to treat interstitial cystitis (IC) which causes chronic pain in the bladder and pelvis area due to inflammation. Research estimates that more than one million people in the United States suffer from IC and most of the sufferers are women.

What are the Side Effects of Elmiron?

The current prescription information provided by Janssen Pharmaceuticals about Elmiron lists the drug’s basic side effects and warnings (see below), but does not provide any information about the risk of maculopathy—the disease that affects the macula—or other visual changes or conditions as a result of taking the medication.

Common Side Effects of Elmiron:

  • Hair loss
  • Diarrhea
  • Nausea
  • Bloody stool
  • Headache
  • Rash
  • Abnormal liver function tests
  • Dizziness
  • Bruising

Visual Side Effects of Elmiron:

  • Conjunctivitis (“pinkeye”)
  • Optic neuritis (inflammation of optic nerve)
  • Amblyopia (“lazy eye”)
  • Retinal hemorrhage (bleeding in retina)

What is Maculopathy?

Maculopathy is a progressive disease that can result in vision loss—usually in both eyes. The disease impacts the part of the eye located in the back of the retina which is called the macula. The macula controls your ability to read, see fine details in objects, recognize faces and colors, and focus central vision.

This is a unique type of maculopathy which has only been found in people taking Elmiron. The condition is distinguishable from age-based degeneration in that it causes a unique pigmentary maculopathy during exposure to Elmiron.

What is the Link Between Elmiron and Maculopathy?

Researchers at Emory University first discovered the potential link between Elmiron (pentosane polysulfate sodium) and Maculopathy (specifically, pigmentary maculopathy) in 2018 when 6 patients were suffering from the condition but did not have any previous retinal issues in their medical history. Researchers discovered that the common thread between all 6 patients was their long-term use of Elmiron.

In Summer 2019, Kaiser Permanente in California followed up on the 2018 study. In the Kaiser Permanente study, 91 of the patients who were taking an average of 5000 Elmiron pills over 15 years participated. Of those 91 participants, 22 participants were found to have significant damage to their retina associated with drug toxicity. The rate of toxicity increased with the amount of Elmiron that had been consumed—from 11% of those taking 500 to 1000 grams to 42% of those taking 1500 grams or more.

Through the studies, researchers identified the following symptoms as being associated with Elmiron-related Maculopathy:

Symptoms Associated with Elmiron-Related Maculopathy from Studies:

  • Difficulty reading
  • Difficulty adapting to dim lighting
  • Areas of vision loss in field of vision
  • Problem seeing options that are close-up
  • Vision dimming

Several subsequent studies have since been performed by researchers where a statistically significant link between long-term Elmiron usage and maculopathy were identified.

A 2019 Harvard study has noted that the condition can worsen over time and is not likely reversible.

GoldenbergLaw Can Help

GoldenbergLaw is currently investigating cases where an individual has taken Elmiron long-term and suffered harm to the eye. We have been litigating complex cases for over thirty years and will fight to bring you the justice and gold standard of advocacy that you deserve.

 

New Testing Finds Dangerous Levels of NDMA Contamination In Metformin

The online pharmacy Valisure recently announced that it found dangerously high levels of the probable human carcinogen N-nitrosodimethylamine (NDMA) in certain batches of the popular type-2 diabetes drug, Metformin. Valisure tested 38 batches of Metformin produced by a range of manufacturers and found levels of NDMA over the Food and Drug Administration’s (FDA) daily acceptable intake limit of 96 nanograms in 16 of these batches. Some of the NDMA levels were found to be over 10 times the daily acceptable limit!

On May 27, 2020, the FDA announced that it had also found high levels of NDMA in certain batches of Metformin and would be contacting the manufacturers of the contaminated medications to take appropriate action.

Valisure’s FDA Citizen Petition

Since this discovery, Valisure filed a Citizen Petition with the FDA and requested that the agency recall the contaminated batches of Metformin. In addition, Valisure implored the FDA to re-examine and modify testing methods to reduce the risk of underestimating NDMA levels.

Within the Citizen Petition, Valisure highlighted how they followed the FDA’s recommended testing protocols, but had also made some revisions to improve the accuracy of the tests.

Previous Valisure investigations and notifications to the FDA about NDMA contamination in the blood pressure medication Valsartan and the popular heartburn medication Zantac contributed to extensive recalls in the United States.

Background Information on Metformin and the FDA

On December 5, 2019, the FDA announced its investigation into the possibility of carcinogen contamination in Metformin. The statement came just one day after Singapore’s national health agency issued a recall of three Metformin medications due to NDMA contamination. Following the statement from Singapore, multiple global health agencies, such as Health Canada and the European Medicine Agency, announced similar investigations.

Just two months later, the FDA announced that it had found trace levels of NDMA contamination in Metformin. However, the FDA claimed that those levels did not exceed the acceptable daily intake limit of 96 nanograms.

New testing in May 2020 found levels of NDMA above the acceptable intake limit. It is possible Metformin recalls may be the agency’s next step in assessing the safety of the medication.

Valisure’s Testing Methods

The FDA used the Liquid Chromatography-High Resolution Mass Spectrometry (LC-HRMS) Method for determining the presence of NDMA in Metformin and published the details of their method on February 4, 2020. The method, which was developed and validated by the FDA, was used to determine the quantity of NDMA present in Metformin.

The method accomplishes its purpose by separating the NDMA impurity from Metformin by reverse phase chromatography (the process of separating hydrophobic moieties and those that do not have a dominant polar character) which is then detected by a high-mass accuracy (HRAM) mass spectrometer.

Quantitation is then performed by comparing the peak area of the NDMA impurity in the extracted ion chromatogram of the samples to the peak area of the NDMA reference standard using external calibration.

Valisure used the testing principle of the FDA’s method but also made modifications to achieve a lower limit of detection (LOD), which allows the tests to be alerted to lower levels of NDMA present in the samples. In addition, Valisure’s method allows for a lower limit of quantitation (LOQ) and a wider reportable range while using the same sample preparation method as the FDA.

As a result of the improvements, Valisure’s methods generates increased chromatographic resolution and sharper peaks demonstrating increased NDMA contamination in Metformin samples.

These optimizations allow Valisure’s testing methods to extract more detail about the amount of NDMA within Metformin samples. Without these improvements, Valisure claims the FDA’s method may have underestimated the NDMA concentration in the Metformin.

Risks of Metformin NDMA Contamination

Valisure’s findings reveal that the danger of NDMA contamination in Metformin may be even more severe than previously estimated by the FDA. The impact of this discovery is compounded by the fact that Metformin is one of the most prescribed drugs in the United States.

Metformin is sold under brand names: Glucophage, Glucophage XR, Fortamet, Riomet and Glumetza, in addition to being sold as a generic. There are dozens of manufacturers who produce and distribute Metformin products in the United States.

Exposure to NDMA beyond the daily acceptable intake limit has been linked to various cancers, such as:

  • Stomach cancer
  • Bladder cancer
  • Intestinal cancer (in both the large and small intestine)
  • Colon cancer / Colorectal cancer
  • Esophageal cancer
  • Liver cancer
  • Prostate cancer
  • Pancreatic cancer
  • Leukemia
  • Non-Hodgkin’s Lymphoma
  • Kidney cancer
  • Multiple Myeloma

How GoldenbergLaw Can Help You

If you or a loved one has been diagnosed with cancer after taking metformin, contact GoldenbergLaw for a free consultation on a metformin lawsuit today. Our Minnesota Cancer Attorneys have over 30 years of experience fighting pharmaceutical corporations and will deliver the Gold standard advocacy you deserve.